Remote Principal Statistical Programmer - Lead, FSP

Cytel; Madison (WI); Remote; USD 120.000 - 180.000; Vollzeit

Zusammenfassung

Cytel is seeking a Principal Statistical Programmer to work embedded with a pharmaceutical sponsor. You will lead programming activities across SDTM/ADaM, develop SAS programs, and oversee CRO deliverables while ensuring FDA-compliant reporting.

The ideal candidate has 7+ years in biostatistics programming, strong SAS expertise, CDISC standards, and experience with regulatory submissions. Excellent communication and leadership skills are required, with the ability to work independently.

Qualifikationen

• At a minimum bachelor’s degree in computer science, data science, mathematics, or statistics major preferred.
• 7+ years of experience as a Statistical Programmer on Biotech/Pharma Clinical Development Biometrics Team or similar.
• Exceptional SAS programming skills and expertise in development and implementation of statistical programming procedures.
• Extensive experience with CDISC standards (SDTM, ADaM, Define.xml).
• Experience supporting regulatory submissions and interactions with FDA/global authorities.
• Ability to work independently.
• Strong written and verbal communication and leadership skills.

Aufgaben

• Generate SDTM, ADaM specifications, datasets, reviewer’s guides and Define.xml files for multiple studies.
• Develop SAS programs to generate datasets, complex listings, tables, and complex graphs in collaboration with statisticians.
• Deliver high-quality statistical programming results; validate and maintain SAS and/or R programs.
• Oversee CRO programming deliverables to ensure quality and timelines across studies.
• Support preparation of clinical study reports, regulatory submissions, DSURs, and exploratory analyses.
• Understand and follow FDA regulations and GCP for electronic submissions.
• Contribute to standards for programming tools, outputs, and macros.
• Develop CRFs, edit checks, and data validation plans.
• Provide review/author data transfer specifications for external vendors.
• Collaborate with CROs, software vendors, and development partners to meet milestones.
• Review and/or author SOPs and Work Instructions for statistical programming practices.

Kenntnisse

SAS programming

CDISC SDTM/ADaM

Statistical programming

R

Python

Unix/Linux

Git

Leadership

Ausbildung

Bachelor’s degree in computer science, data science, mathematics, or statistics

Tools

SAS

R

Define.xml

Jobbeschreibung

Cytel is seeking a Principal Statistical Programmer to work embedded with a pharmaceutical sponsor. You will lead programming activities across SDTM/ADaM, develop SAS programs, and oversee CRO deliverables while ensuring FDA-compliant reporting.

The ideal candidate has 7+ years in biostatistics programming, strong SAS expertise, CDISC standards, and experience with regulatory submissions. Excellent communication and leadership skills are required, with the ability to work independently.